Microbiological and Organizational Impact of the Use of Bacteriologically Controlled Water in COLOscopy

ConditionColonoscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

A joint opinion of the SFED and the SF2H recommends to orient our colonoscopy practices towards the use of bacteriologically controlled water in reusable bottles for colonic irrigation. To date, no study exists to validate the proposed set-up. Our main objective is therefore to evaluate the microbiological safety of the use of bacteriologically controlled water, in particular the absence of retro contamination of the water in the wash bottle by the faecal flora of the patient undergoing colonoscopy, in order to be able to generalise this practice

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients with a colonoscopy indication whose examination is scheduled in room 4, on a Monday and Tuesday shift (8:30 a.m. - 1:30 p.m.)

Male or female of legal age at the time the colonoscopy is ordered

Patient willing to participate in the study

Person affiliated with or benefiting from a social security plan

Disqualifiers

Pregnant woman

Patient of legal age under guardianship or protected person

Patient requiring indigo-carmine chromoendoscopy

Patient requiring an emergency colonoscopy

Trial design

Design model

Single group

Treatments tested in this trial

  • Colonoscopy with Bacteriological Controlled Water

    Procedure/Surgery

    Patient with coloscopy which used Bacteriological Controlled Water : Collection of 250 ml of bacteriologically controlled water from the wash bottle at the end of each water-assisted colonoscopy to test for enterobacteria and fecal streptococci

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Patient with Bacteriologically Controlled Water procedureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of back contamination

Rate of back contamination after colonoscopy using the EBM procedure. The absence of retro-contamination is defined as the absence of fecal flora (enterobacteria and fecal streptococci) in the wash bottle during the bacteriological analysis of the EBM microbiological samples taken after each colonoscopy

Time frame
inclusion visit

Secondary outcomes

1

Workload

Estimation of the workload in minutes, per person involved and for each phase of the reusable vial circuit

Time frame
Inclusion visit
2

Satisfaction and acceptability healthcare professionals

Evaluation of satisfaction and acceptability among healthcare professionals using the French version of the System Usability Scale (FSUS).

Time frame
Inclusion visit
3

Acceptability patient

Assessment of patient acceptability of Bacteriologically Controlled Water use by counting the total number of patients offered the study to obtain 40 consents

Time frame
Inclusion visit
4

Infectious episode

Monitoring the occurrence of an infectious episode (D+1 and D+7) characterized by the occurrence of a fever episode higher than 38.5°C.

Time frame
DAY 1 VISIT AND DAY 7 VISIT

Other outcomes

Sponsors and contacts

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